MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VXAK0005
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.Detailed product information was not provided to bsc.We completed theh effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress, but further information was unable to be obtained.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a cardiac tamponade, pericardial effusion (pe) and perforation occurred.The procedure was cancelled.During a watchman flx pro procedure, a versacross connect laac was selected for use.Patient's septal anatomy was challenging to visualize; after minutes of confirming safe transeptal location an radio frequency (rf) application was performed and the wire crossed the septum.However, the wire went into a transverse sinus area leading to blood getting into the pericardium causing a hole approximately.035' posterior to the aorta.The patient was observed to be developing an effusion and eventually developed tamponade.A pericardiocentesis was performed and approximately 450cc of blood was aspirated from the pericardium.The procedure was aborted and the patient was brought to the intensive care unit (icu) for further observation.After thirty (30) minutes to an hour had gone by, a transesophageal echocardiogram (tee) was performed to reassess the effusion.Unfortunately the effusion came back and the patient was taken to the operation room where the cardiothoracic surgeon repaired the hole and ligated the appendage with an atriclip.The patient is expected to fully recover.The device is not expected to be returned for analysis (disposed).
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the updated field describe event or problem (b5), in section b - adverse event or product problem.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.
Event or Problem Description
It was reported that a cardiac tamponade, pericardial effusion (pe) and perforation occurred.The procedure was cancelled.During a watchman flx pro procedure, a versacross connect laac was selected for use.Patient's septal anatomy was challenging to visualize; after minutes of confirming safe transeptal location an radio frequency (rf) application was performed and the wire crossed the septum.However, the wire went into a transverse sinus area leading to blood getting into the pericardium causing a hole approximately.035' posterior to the aorta.The patient was observed to be developing an effusion and eventually developed tamponade.A pericardiocentesis was performed and approximately 450cc of blood was aspirated from the pericardium.The procedure was aborted and the patient was brought to the intensive care unit (icu) for further observation.After thirty (30) minutes to an hour had gone by, a transesophageal echocardiogram (tee) was performed to reassess the effusion.Unfortunately the effusion came back and the patient was taken to the operation room where the cardiothoracic surgeon repaired the hole and ligated the appendage with an atriclip.The patient is expected to fully recover.The device is not expected to be returned for analysis (disposed).It was further reported that the anatomy was difficult to image, but the wire was easily visualized once the physician was able to find the tenting on tee.Act was therapeutic.The patient has been discharged.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23773807
• Report Number: 2124215-2025-90259
• Device Sequence Number: 20339322
• Product Code: DXF
• UDI-Device Identifier: 00685447010517
• UDI-Public: (01)00685447010517
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: VXAK0005
• Device Catalogue Number: VXAK0005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White